Asthma
Conditions
Brief summary
To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a extrafine pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids
Interventions
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
DRUGFoster
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Outpatients of both sexes, aged \> 12 years * Moderate to severe symptomatic asthma * Forced expiratory volume in the first second (FEV1) \> 40% and \< 80% of the predicted normal values * Reversibility test * Partly controlled asthma (GINA revised 2006) * Patients free of long-acting beta2-agonists (LABAs) treatment * Under inhaled corticosteroids (ICS) treatment * A minimum inspiratory flow ≥ 40 L/min 10. * Non-smokers or ex smokers * Asthma Control Questionnaire ACQ score ≥ 1.5
Exclusion criteria
* Pregnant or nursing (lactating) women * Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception * Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer * History of near fatal asthma * Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit * Diagnosis COPD * History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency * Diagnosis of restrictive lung disease * Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids) * Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids * Allergy to any component of the study treatments * Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit * Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ; * Patients with abnormal QTc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic | 3 month period |
Secondary
| Measure | Time frame |
|---|---|
| Post-dose FEV1 AUC 0-8 h | 3 month period |
| FVC and FEF 25-75% | every month |
| PEF | every day |
| Pre-dose FEV1 | every month |
| Moderate and severe exacerbations | every month |
| Rescue medication | every day |
| Sputum | 3 month period |
| Morning and evening asthma clinical symptoms scores | every day |
Countries
Germany
Outcome results
None listed